19 results
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27ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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PERIMETER INTERBODY FUSION DEVICE
FDA 510(k)
FDA Class 2
·Orthopedic
7450 RV2 MASK
FDA UDI
HANS RUDOLPH, INC.·00817136021386·7450 V2 EXSM W/HG & 2700 NRBV
CapSure® Spine System
FDA UDI
Spine Wave, Inc.·10840642104998·PS3 Screw 6.5mm x 40mm
GLOBAL
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295006985·GLOBAL ANCHOR PEG GLENOID SIZE 48mm CEMENTED
GLOBAL
FDA UDI
DEPUY ORTHOPAEDICS, INC.·10603295006992·GLOBAL ANCHOR PEG GLENOID PREMIERON X-LINKED PE...
AVEA
FDA 510(k)
FDA Class 2
·Anesthesiology
SILJETR SYSTEM
FDA 510(k)
FDA Class 2
·Dental
DEPUY SHOULDER SYSTEM
FDA Adverse Event
Injury
·DEPUY ORTHOPAEDICS INC.·Product code KWS·December 6, 2017
AQUILEX FLUID CONTROL SYSTEM
FDA Adverse Event
Malfunction
·W.O.M. WORLD OF MEDICINE GMBH·Product code HIG·March 12, 2020
TALENT
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·October 26, 2018
VALIANT STENT GRAFT
FDA Adverse Event
Malfunction
·MEDTRONIC IRELAND·Product code MIH·October 26, 2018
TALENT TAA STENT GRAFT
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·October 26, 2018
VALIANT STENT GRAFT
FDA Adverse Event
Death
·MEDTRONIC IRELAND·Product code MIH·October 26, 2018
TALENT TAA STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·October 26, 2018
VALIANT STENT GRAFT
FDA Adverse Event
Injury
·MEDTRONIC IRELAND·Product code MIH·October 26, 2018
MICRO ZURICH DISTRACTOR
FDA Adverse Event
Injury
·KARL LEIBINGER MEDIZINTECHNIK GMBH & CO. KG·Product code MQN·May 9, 2013
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·September 24, 2014
CD HORIZON SPINAL SYSTEM
FDA Adverse Event
Malfunction
·WARSAW ORTHOPEDIC, INC.·Product code KWP·June 3, 2011
Model Number L231, PROPONENT DR EL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025